Lumax Family of ICDs and CRT‑Ds - BIOTRONIK USA - News

2 Lumax Family Technical Manual
• Lumax VR—provides single chamber rate adaptive bradycardia
pacing support as well as tachyarrhythmia detection and therapy.
• Lumax VR‐T—In addition to the functionality found with standard
VR model, it also has BIOTRONIK’s Home Monitoring System.
The Home Monitoring System enables automatic exchange of
information about a patient’s cardiac status from the implant to the
physician remotely.
• Lumax VR-T DX – provides ventricular rate adaptive bradycardia
pacing support that can include atrial tracking with a single pass
ICD lead and also has BIOTRONIK’s Home Monitoring system.
The 300⁄500 and 340⁄540 designation for each of the above‐described
models denote the maximum programmable shock energy of 30 joules
and 40 joules, respectively.
The Lumax 500⁄540 models also feature a third programmable shock
path for delivery of defibrillation⁄cardioversion shocks. The shock path
is programmable between the different shock coils (SVC⁄RV) and⁄or the
device housing. Section 2.7.3.6 provides further details on the available
shock configurations.
Additionally, the Lumax 500⁄540 models feature Automatic Threshold
Measurement (ATM) of ventricular pacing thresholds. This feature
is separately programmable for the right (RV) and left (LV) ventricle.
Section 2.3 provides further details.
The Lumax HF (‐T) models have three IS‐1 pacing⁄sensing header ports
and two DF‐1 defibrillation⁄cardioversion ports. The Lumax DR (‐T)
models have two IS‐1 pacing⁄sensing header ports. The Lumax VR (‐T)
models have one IS‐1 pacing⁄sensing header ports. IS‐1 refers to the
international standard whereby leads and generators from different
manufacturers are assured a basic fit [Reference ISO 5841‐3:1992].
DF‐1 refers to the international standard for defibrillation lead
connectors [Reference ISO 11318:1993].
External devices that interact with and test the implantable devices are
also part of the ICD⁄CRT‐D System. These external devices include the
ICS 3000 Programming and Tachyarrhythmia Monitoring System and
the Implant Module System Analyzer or Pacing System Analyzer for
acute lead testing. The ICS 3000 programmer is used to interrogate and
program the ICD⁄CRT‐Ds.
BIOTRONIK conducted the TRUST study to evaluate the safety and
effectiveness of Home Monitoring, which is available in some models of
this device. Refer to Section 1.6.4 for details regarding the study design